Infant, Very Low Birth WeightNCT01799629
Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
A study testing Glycerin suppositories in people with Infant, Very Low Birth Weight, run by King Faisal Specialist Hospital & Research Center at 3 sites in Saudi Arabia.
Trial summary
To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Infant, Very Low Birth Weight
- What is being tested?
- Glycerin suppositories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesSaudi Arabia
- Study dates
- Mar 2013to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants with birth weight < 1250g.
- Inborn or outborn infants
- Less than 72 hours of age.
Who cannot join
- Congenital malformations.
- Acute abdomen needing surgical intervention.
- Severity of illness such that death is likely in the first few days after birth.
- Inability to get the parental consent.
Trial locations and contacts
3 sites in 1 country.
Saudi Arabia3 sites
King Faisal Specialist Hospital & Research Centre
Riyadh, 11211
Security Forces Hospital
Riyadh
Sulaiman Al habib Medical Center
Riyadh
About this study
To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants
- Conditions
- Infant, Very Low Birth Weight
- Being tested
- Glycerin suppositories
- Keywords
- Glycerin suppositories, Feeding intolerance, preterm infants, prophylactic use, elimination of meconium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerin suppositoriesDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group will receive the glycerin suppository Receives: Drug: Glycerin suppositories |
| Control | No intervention | Normal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)
Measured: 2years
Secondary outcomes (2)
Incidence of feeding intolerance
which is defined by the presence of GRVs > 50 % of the previous feed for two consecutive feeds in addition to two of the following: I. Abdominal distention > 1 cm in 12 hour. II. Abdominal tenderness. III. Vomiting. IV. Bile stained aspirate.
Measured: 2years
Incidence of necrotizing enterocolitis (NEC)
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2022
- Study completionDec 2022
Why it stopped: Recruitment issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Sulaiman Alhabib Medical City, Riyadh, Security Forces Hospital
- Responsible party
- Principal investigator, Emad Mohammad Khadawardi, King Faisal Specialist Hospital & Research Center
- Investigators
- Emad M Khadawardi, MD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799629
- Sponsor's protocol ID
- 2121 110
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2013
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01799629
- Acronym / sponsor ID
- 2121 110
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- Glycerin suppositories, Feeding intolerance, preterm infants, prophylactic use, elimination of meconium
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issue
- Enrolment
- 220 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Collaborators
- Dr. Sulaiman Alhabib Medical City, Riyadh, Security Forces Hospital
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Glycerin suppositoriesIntervention group will receive the glycerin suppository |
| Control | No intervention | –Normal care |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants with birth weight < 1250g.
- Inborn or outborn infants
- Less than 72 hours of age.
Key exclusion criteria (4 listed)
- Congenital malformations.
- Acute abdomen needing surgical intervention.
- Severity of illness such that death is likely in the first few days after birth.
- Inability to get the parental consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycerin suppositories | Drug | Intervention |
Primary outcome
days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)
Time frame: 2years
2 secondary outcomes
Incidence of feeding intolerance
Time frame: 2years
Incidence of necrotizing enterocolitis (NEC)
Time frame: 2years
Results and safety
The study was stopped early (reason given: Recruitment issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad M Khadawardi, MD principal investigator
King Faisal Specialist Hospital & Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycerin suppositories in people with Infant, Very Low Birth Weight, run by King Faisal Specialist Hospital & Research Center at 3 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day) (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.